Protective efficacy of a live attenuated vaccine against Argentine hemorrhagic fever. AHF Study Group.
Argentine hemorrhagic fever (AHF), caused by the arenavirus Junin, is a major public health problem among agricultural workers in Argentina. A prospective, randomized, double-blind, placebo-controlled, efficacy trial of Candid 1, a live attenuated Junin virus vaccine, was conducted over two consecutive epidemic seasons among 6500 male agricultural workers in the AHF-endemic region. Twenty-three men developed laboratory-confirmed AHF during the study; 22 received placebo and 1 received vaccine (vaccine efficacy 95%; 95% confidence interval [CI], 82%-99%). Three additional subjects in each group developed laboratory-confirmed Junin virus infection associated with mild illnesses that did not fulfill the clinical case definition for AHF, yielding a protective efficacy for prevention of any illness associated with Junin virus infection of 84% (95% CI, 60%-94%). No serious adverse events were attributed to vaccination. Candid 1, the first vaccine for the prevention of illness caused by an arenavirus, is safe and highly efficacious.
Maiztegui
J I
JI
Instituto Nacional de Estudios sobre Virosis Hemorrágicas (Instituto Nacional de Enfermedades Virales Humanas Julio I. Maiztegui), Pergamino, Argentina.
McKee
K T
KT
Barrera Oro
J G
JG
Harrison
L H
LH
Gibbs
P H
PH
Feuillade
M R
MR
Enria
D A
DA
Briggiler
A M
AM
Levis
S C
SC
Ambrosio
A M
AM
Halsey
N A
NA
Peters
C J
CJ
D000293:Adolescent; D000328:Adult; D000382:Agricultural Workers' Diseases / Q000517:prevention & control / Q000628:therapy / Q000821:virology; D000818:Animals; D000914:Antibodies, Viral / Q000032:analysis / Q000276:immunology; D006477:Arenaviruses, New World / Q000254:growth & development / Q000276:immunology*; D001118:Argentina; D002478:Cells, Cultured; D002522:Chlorocebus aethiops; D004311:Double-Blind Method; D006478:Hemorrhagic Fever, American / Q000175:diagnosis / Q000517:prevention & control* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012621:Seasons; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000627:therapeutic use*; D014709:Vero Cells; D014765:Viral Vaccines / Q000009:adverse effects / Q000627:therapeutic use*
D000914:Antibodies, Viral; D014613:Vaccines, Attenuated; D014765:Viral Vaccines